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Clinical Trial Summary

This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine whether chlorhexidine gluconate (CHG) cleansing decreases central line associated bloodstream infection (CLABSI) in children with cancer or those receiving an allogeneic hematopoietic cell transplantation (HCT). SECONDARY OBJECTIVES: I. To determine whether CHG cleansing decreases acquisition of multi-drug resistant organisms (MDRO: vancomycin resistant enterococci [VRE], methicillin resistant Staphylococcus aureus [MRSA], etc.) in children with cancer or those receiving allogeneic HCT. II. To determine whether CHG cleansing in children with cancer or those receiving allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility to CHG. III. To determine whether CHG cleansing decreases positive blood cultures in children with cancer or those receiving allogeneic HCT. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD) for 90 days. ARM II: Patients receive control cleansing with topical skin wipes QD for 90 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01817075
Study type Interventional
Source Children's Oncology Group
Contact
Status Completed
Phase Phase 3
Start date November 4, 2013
Completion date March 31, 2020

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